The US Food & Drug Administration (FDA) has cleared the Senhance System, a robotically assisted surgical device (RASD) that can be used during minimally invasive surgery.
“RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites,” stated Binita Ashar, MD, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.
The Senhance System allows surgeons to sit at a console unit that provides a high-definition view of the surgical field and to control 3 separate robotic arms remotely during laparoscopic surgery. The end of each arm is equipped with surgical instruments that have unique technological characteristics: force feedback, which helps the surgeon “feel” the stiffness of tissue being grasped by the robotic arm, and eye-tracking, which helps control movement of the surgical tools.
A clinical study was conducted of 150 patients undergoing various gynecologic operations with the Senhance System. Clinical outcomes were compared with those described in 8 peer-reviewed research publications involving more than 8,000 gynecologic operations performed in real-world settings using another RASD, the da Vinci Si IS3000.
The FDA concluded that these study data, along with performance testing under simulated use and worst-case scenario conditions, demonstrated the substantial equivalence of the Senhance System to the da Vinci Si IS3000 device for gynecologic and colorectal procedures.
FDA clears new robotically-assisted surgical device for adult patients [news release]. US Food & Drug Administration. October 13, 2017. Accessible at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm580452.htm